Purpose of Position :
The Senior Design Assurance (DA) Engineer works as an integral part of the CathX Medical engineering team responsible for designing and manufacturing high quality medical products.
The Sr. DA is the leading voice of quality in new product development, technology transfers, and process development. Responsible to provide Design Assurance Engineering support for TX and DV projects as detailed below :
Essential Functions :
Establish design verification protocols and reports with input from the project manager and manufacturing engineering.
Perform independent verification of test data and analyze results.
- Draft or provide input on test methods, test method validation, and general testing requirements to ensure that standards, regulations and guidance document criteria are met.
- Support process validation and technology transfer studies for special processes to improve CathX Medical quality assurance methodology.
- Develop master validation plans and reports based on input from customers' and project teams.
- Review and provide input on calibration, preventive maintenance, IQ / OQ, PQ and software validation protocols for inspection, measuring, manufacturing, and testing equipment.
- Support all aspects of risk management including hazard analysis, Design FMEA and Process FMEA for DV and TX projects.
- Obtain and gain agreement on any special quality, test, and certification requirements in cooperation with the project team and assure overall agreement between CathX Medical and customer drawings and specifications for DV and TX projects.
- Draft and execute design of experiments (DOE) and capability studies with the input and support of the manufacturing engineer and project manager.
- Work as a part of a core team with R&D, Project manager, Manufacturing engineering and business development as required in new product introduction for DV and TX projects.
- Perform statistical analysis of test data and inspection results for new product introduction.
- Perform internal audits as part of an audit team at the direction of the lead auditor.
- Promote a culture of compliance to company procedures.
Required Experience, Knowledge, Skills, Abilities or Education :
- Five or more years of experience in quality engineering, manufacturing engineering, and project engineering.
- BS degree in science, engineering, or manufacturing or equivalent experience or certifications.
- Demonstrated expertise in quality concepts, practices, and procedures.
- Strong interpersonal skills are required.
- Ability to plan, establish and coordinate test and inspection procedures, conduct process capability studies, prepare statistical quality control data and develop statistical designed experiments.
- Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
- Ability to travel as necessary.
- Ability to work in a virtual or remote location.
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